Project Scope |
This project team will create a White Paper with recommendations for Adverse Event Collection Instructions, with a focus on Phase 2-4 clinical trials. This project will build upon a paper that outlines results from a survey on current practices, indicating variation that can likely be reduced. Recommendations will be based on the desired end-in-mind, and may or may not be consistent with current practices. |
| Project Leads | Emails |
|---|---|
Aimee Basile, Coherus Biosciences | |
Mary Nilsson, Eli Lilly | |
Nicola Newton, PHUSE Project Assistant |
CURRENT STATUS Q4 2023 |
|---|
Continue to progress the White Paper, with edits and reviews |
| Published Deliverables | Date |
|---|---|
| Blog – Investigator Assessment of Causality – Opportunity for Simplification? | 15-Dec-2021 |
| Adverse Event Collection & Treatment Emergent Collection: Version 1.0 | 27-Aug-2020 |
| Objectives & Deliverables | Timelines |
| Publish White Paper | Q2 2024 |